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Which kidney stone procedure works best for dense stones? a Head-to-Head trial

NCT ID NCT04856722

Disease control Sponsor: Al-Azhar University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This trial compares three common procedures—mini-PNL, RIRS, and SWL—for treating medium-sized (10-20 mm), dense (over 1000 HU) kidney stones located outside the lower pole. Researchers aim to see which method offers the best stone-free rate, fewest complications, lowest cost, and highest patient and surgeon satisfaction. Adults with a single stone of this type are randomly assigned to one of the three procedures and followed for three months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mini-PNL, RIRS, and SWL procedures
What this could lead to
If one method proves clearly better, it could become the preferred treatment for medium-sized, dense kidney stones, improving outcomes and reducing complications.
What could go wrong
This is a single-center trial, and results may not apply to all stone types or locations. Each procedure carries risks like infection, bleeding, or incomplete stone removal.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

253 people

The number who actually took part.

Started

Apr 2021

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients (both genders) * Single non-lower pole renal stone. * Stone size: 10-20 mm. * Stone density: \> 1000 HU. Exclusion Criteria: * Pregnant women. * Morbid obesity. * Severe orthopaedic deformities. * Co-morbidities precluding general anaesthesia or prone positioning. * Uncorrectable coagulation disorders. * Active urinary tract infection (UTI). * Stone in a calyceal diverticulum. * Abnormal renal anatomy. * Urinary tract obstruction distal to the stone. * Concomitant pathology that needs intervention in the same setting. * Advanced hydronephrosis.

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Conditions

The condition(s) this trial relates to.

nephrolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extracorporeal shockwave lithotripsy Percutaneous nephrolithotomy Renal stone Retrograde intrarenal surgery

Contacts and locations

Locations

  • Urology Department, Al-Azhar University Hospital

    Cairo, 11633, Egypt

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